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Zicam and Orajel Swabs Recalled for Possible Fungal Contamination

Physician's Weekly

Food and Drug Administration (FDA) after the manufacturer, Church & Dwight Co., Swabs that are contaminated with fungi can lead to serious infections, especially in children, people with weakened immune systems or those with other medical conditions. So far, no illnesses or serious injuries have been reported, CBS News said.

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The Future Of Vision And Eye Care

The Medical Futurist

Treating less serious ailments gets faster, more targeted and more efficient, while the means for curing more serious and life-altering illnesses improve. However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. The drug helped decrease the initial healing from 5 days.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. After all, Lilly offered access to treatment for critically ill patients in financial need who would otherwise have to forego treatment or be saddled with a $13,000 per year copay. Background.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Green Practice News: May 2025

My Green Doctor

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

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FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. The regulatory uncertainty has ill?befitted befitted a very important pathway to market for novel medical devices. The new rule will be codified in 21 C.F.R. FDCA § 513(f)(5).

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Or, do we know anything even how common it is, serious illness, palliative care populations? How to screen for hearing loss. Eric: And how do we screen for it? .” It’s amazing.

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